The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.

The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]

The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]

KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.

KHQ consists of the following domains:

General health perceptions (GHP)

Impact on life

Role limitations

Physical limitations

Social limitations

Personal relationships (PR)

Emotions

Sleep/energy

Incontinence severity measures (ISM)

Change: mean at Week 28 and 52 minus mean at Baseline

Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]

OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).

Change: mean at Week 28 and 52 minus mean at baseline

The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]

The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:

no problems at all

some very minor problems

some minor problems

some moderate problems

severe problems

many severe problems

Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00658684